Concrete industrial case studies of decision-making AI

Computerized systems are central to every GxP process but ensuring they perform reliably and compliantly requires structure and discipline.
This session lays the groundwork: what CSV means, why it exists, and how risk-based approaches ensure trust in system performance, product quality, and patient safety.

Participants will:
- Define CSV and its role in maintaining product quality and data integrity.
- Identify key regulatory drivers (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
- Understand the CSV lifecycle (planning, specification, verification, reporting).
- Recognize how critical thinking and CSA principles modernize validation.
- Build shared understanding between IT, QA, and Business roles.

Key Takeaways
- Validation = documented evidence of control.
- Focus on what is critical - not on volume of documentation.
- Collaboration between IT, QA, and Business is essential for compliance and efficiency.